Addiction
Conditions
Keywords
Opiate dependence, Deep brain stimulation, Nucleus accumbens
Brief summary
Nucleus accumbens plays important roles in the process of opiate addiction and initial of relapse after detoxification.According to the single-centered preliminary open-labeled prospective trial results, the investigators hypothesize that bilateral stimulation of the NAc will effectively reduce the relapse of the opiate dependence.
Interventions
We plan to use the SceneRay 1242 (SceneRay, SuZhou, China) electrode with a diameter of 1.27 mm and 4 contacts. The SceneRay 1242 electrode combined with the SceneRay 1181 implantable pulse generator has the advantage of adaptive coverage area for the Ventral Capsule/Ventral Striatum, enabling simultaneous implantation in the nucleus accumbens (NAc; 2 ventral contacts) and the anterior limb of the internal capsule (ALIC; 2 dorsal contacts) with independently programmed parameters such as frequency, amplitude, and voltage; and remote and wireless programing, which allows for convenient and prompt adjustments in emergency situations.
Sponsors
National Institute on Drug Dependence, Peking University
Ruijin Hospital
West China Hospital
Nanfang Hospital, Southern Medical University
Peking University First Hospital
Tang-Du Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Stagger-on design
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 18 years old \< Age \< 50 years old * Moderate to severe opiates abuse disorders (fulfilled diagnostic-criteria according to DSM-5) 1. History of opiates abuse no less than 3 years 2. Failure of at least three addiction treatments ( in hospital or compulsive rehabilitation）, among which failure of methadone maintenance treatment must be met 3. completion of detoxification ( Negative urine test for morphine, methamphetamine, ketamine and buprenorphine) * Free patient's decision/informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance, known the benefit and risk of the treatment)
Exclusion criteria
* Clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases, severe personality disorder) * Contraindications of a MRI-examination, e.g. implanted cardiac pacemaker/heart defibrillator * Abuse of other type of drugs * severe cognitive impairments * Enrollment in other clinical trials * Stereotactic respectively neurosurgical intervention in the past * Contraindications of a stereotactic operation, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases) * Serious and instable organic diseases (e.g. instable coronal heart disease) * tested positively for HIV * pregnancy and/or lactation * Severe disorders for coagulation and liver function * Epilepsy or other severe brain trauma or neurological impairments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The abstinent rate at 25 weeks after DBS stimulation on （Urine Tests） | At 25 weeks after DBS stimulation on | If the participants or their families report no less than 2 times of the drug use in each of two consecutive weeks, or the consecutive 2 times of urine tests showed positive, or lost of follow-up, the case was defined as relapse |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The longest duration for sustained abstinence for participants | Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on | The longest duration for sustained abstinence for participants |
| Visual analog scale (VAS) craving score for opioid drugs | Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on | Ranging from 0-10,with 0 indicates no craving while 10 indicates extreme craving |
| Body weight for participants | Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on | Body weight for participants |
| Hamilton Depression Scale（HAMD-17) | Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on | 17 items,Total scores\<7: normal;7\<Total scores\<17:possible depression;17\<Total scores\<24:definite depression;Total score\>24: severe depression |
| Scaling for Opiate withdrawal symptoms | Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on | There were 19 items for rating 19 withdrawl symptoms, with 0 indicating none and 4 indicating most severe, the total scores are obtained by summary for scores of each items, ranging from 0-76, the higher the total scores indicating the worsen opiate withdrawl symptoms. |
| The evaluation on MATRICS-test | Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on | Software system constructed by MATRICS company, which was used for evaluate the cognitive function of the participants |
| The total days of abstinence for participants | Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on | The total days of abstinence for participants |
| Hamilton Anxiety Scale (HAMA) | Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on | 14 items, Total scores\<6: normal;7\<Total scores\<14:possible anxiety;14\<Total scores\<21:definite anxiety;Total score\>21: severe anxiety |
| Pittsburgh sleep quality index(PSQI) | Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on | Scaling for evaluating the sleep quality, the higher total scores indicating the more difficulties on sleep, thus the higher total scores indicating the worsen sleep quality |
| Fagerstrom Test Nicotine Dependence assessment (FTND) | Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on | Scaling for Nicotine Dependence: The higher of scores indicating higher lever of Nicotine Dependence |
| Social Disability Screening Schedule (SDSS) | Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on | Scaling for Social Disability with 10 items, the higher total scores indicating the much severe social disability |
| Activity of Daily Living Scale (ADL) | Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on | Consists of Physical Self-maintenance Scale and Instrumental Activities of Daily Living Scale, ranging from 0-56, total scores \<14, normal; total score \>14, ADL dysfunction |
| 36-Item Short Form Health Survey (SF-36) | Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on | Scaling for Quality of life with 8 subscales, the higher total scores indicating the better quality of life. |
| The rate of positive urine test results | Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on | times of positive urine test/ total times of urine test |
Countries
China
Contacts
Primary ContactGuodong Gao, M.D.
Backup ContactLin Lu, M.D.
Outcome results
None listed